Q&A with Vicki Lewis, human factors engineer at Healthcare Safety Strategies, LLC

When an end-user is not able to use a device correctly they often think it’s their fault when it really is an issue with the design of the device. Vicki Lewis, a human factors engineer at Healthcare Safety Strategies, LLC spoke with HealthCare Business News about how an end-user can recognize usability problems and what manufacturers and health care technology managers need to do to solve them.

HCBN: Who are HTMs and what role do they play in patient care and safety?
VL: Health care technology managers are the people who implement and maintain health care technologies in different environments. For example, a hospital has HTM staff who are in charge of making sure that the equipment is performing correctly. HTM professionals may also go to patient’s homes if they have new technology for home care. They really serve in a variety of roles that support a device, so they see how end users are using a product.

HCBN: What skills should an end-user look for in a HTM?
VL: The most obvious thing is a professional who understands the mechanical, electrical, and computer functions of a device. However, I think that there is a lot of opportunity for health care technology managers to act as a safety layer between an end-user of a device and the manufacturer.

It’s very common for health care technology managers to get a phone call from someone because a device is not working properly. If trained with some knowledge of human factors and usability, the health care technology manager may realize that the device is working as designed but is difficult to use correctly.

The health care technology manager really has the opportunity to serve in this vital role of looking a little more carefully at how the device is being used and why the end user is struggling to use the device correctly. If they have the training, they can act as liaison between the end-user and the medical device vendor to let them know that there are usability problems, which may also be safety problems. Of course, these usability problems should be reported to the FDA.

HCBN: How should an end-user go about talking to a HTM about a usability problem?
VL: First, if an end-user can’t get a device to do what they need it to, then the health care technology manager can make sure that the device is mechanically functioning correctly. Then, if the device is functioning properly, an end-user and HTM professional can talk about how the device is actually being used. It could be something as simple as the coding of the buttons being confusing.

For example, we all associate green with go and red with stop. Buttons on devices should follow this stereotype. However, end-users have accidentally powered down a charged defibrillator by pressing the green “go” button when they mean to press a red button to deliver a shock.

Beyond button coding, a user-centered defibrillator design would confirm that the user really wanted to power down the charged defibrillator. After all, if a non-safety critical device like a projector can ask if you meant to power down, a medical device can.

HCBN: What questions regarding usability problems should an end-user ask a manufacturer before purchasing their product?
VL: Before purchasing any product it’s very important to find out from the vendor if usability testing has been conducted with representative end users. If the end-user of the device is an ICU nurse in a hospital for example, it’s important that usability testing be done with ICU nurses in an environment that is similar to the one in which they work.

The testing should be done with at least 15 people who are representative end-users, according to the FDA.

If a medical device manufacturer hasn’t done testing that meets the recommended guidelines from the FDA for usability evaluation, then the buyer can look at their purchasing options. Also, the end-user or their organization may decide to have independent usability testing conducted before making a purchase.